Under fire, FDA looks to change

Acting chief of agency weighs calls for openness

MaggieMcNeil

WASHINGTON (CBS.MW) -- Troubles surrounding the ImClone Systems insider-trading case are prompting some soul searching at the powerful Food and Drug Administration about its secretive ways.

"We've learned there is a changing atmosphere in the country and in the Congress ... The will of the people is that they want more information," Lester Crawford, the agency's acting commissioner, said in an interview.

The federal agency has come under criticism for its role in the ImClone debacle, and before that its lack of a Senate-confirmed commissioner for the past 18 months. Crawford has been filling in as the acting head of the sprawling agency since February. See Weekend Edition on avoiding the next ImClone.

In the wake of the controversy over who-knew-what in FDA's review of Erbitux, ImClone's once-promising cancer drug, talks are beginning with Congress and the White House over how to get out more information to the public on agency proceedings, while still protecting trade secrets and the privacy of the company. See primer on the drug-approval process.

"There's a new attitude towards more transparency ... I don't know what the answer is," said Crawford. "The system we have is grounded in law, but the national debate has begun."

Officials at the FDA are used to being damned if they do and damned if they don't.

Responsible for regulating more than $1 trillion worth of products ranging from the latest cancer-fighting drugs and intricate pacemakers to food additives and animal growth hormones, the agency normally stirs up controversy in its decisions and often finds itself in no-win situations.

In drug approvals, the FDA either drags its feet in signing off on new life-saving medicine, or it acts too quickly and allows the marketing of too many inadequately tested drugs. It all depends on your perspective.

Nearly two-thirds of 160 cancer specialists in a recent poll complained that the FDA is too slow in approving new drugs and medical devices. While giving the agency credit for slashing the average time for new drug approvals from almost two years in the early 1990's to less than a year in 1999, the doctors said more work needs to be done.

But a study in the Journal of the American Medical Association, released the same day as the poll of the cancer doctors, drew the opposite conclusion. The review focused on the rising incidents of harmful side effects from newly approved drugs, and recommended a more cautious approach in approving new drugs "when safe, effective therapies already exist."

Congressional criticism

Now FDA officials are drawing the wrath of lawmakers for the agency's role in the ImClone blowup.

Rep. Billy Tauzin, (R-La), head of the House Energy and Commerce Committee, said the FDA's review process "failed investors" by allowing ImClone
IMCL, +6.11%
to talk up the drug before it was approved, and then leaking the word that the drug was going to be rejected.

The head of the committee investigating the ImClone case, Rep James Greenwood (R-Pa.), said a more open drug-review process may have prevented the company's sharp rise on investor's high expectations, and then its fall on disappointment on the review rejection.

FDA's Crawford said he and other officials have a newfound appreciation of the impact of the agency and that they're willing to listen to suggestions for change.

"It has now dawned on everyone that FDA is probably not only the most important agency in the United States, but in the world ... It's no longer enough to just say we can't say anything," he noted.

Confirmation lacking

The agency -- along with the White House -- has also come under increasing criticism for lacking a congressionally confirmed commissioner for the past 18 months.

President Bush removed Henney shortly after he took office in January 2001, and the agency's been without an official commissioner ever since -- one of the longest stretches in agency history without confirmed leadership.

Crawford, a respected food-safety expert and head of FDA's Center for Veterinary Medicine in the 1980's, was appointed Deputy Commissioner this past February, and immediately assumed the role of acting head of the agency.

While he's gotten high marks for assertively and ably taking the helm, industry observers are worried that the lack of a Senate-confirmed boss in such a high-profile post is harming the general function of the agency, and has begun to slow the all-important product-approval process.

"The people at the FDA are afraid of making calls, because they don't have anyone to back them up," said Carl Fedlbaum, president of the Biotechnology Industry Organization, a trade group.

Last month more than 100 members of the group wrote to Bush commending the appointment of Crawford, but urging him to name a commissioner, saying, "We cannot stress enough the importance of filling this position."

Since the FDA commissioner selection requires Senate approval, the appointment has become highly politicized.

The nominee first has to pass muster in the Senate Health, Education, Labor and Pensions Committee headed by Massachusetts Democrat Ted Kennedy. Kennedy has vowed not to approve anyone too closely tied to any of the industries the FDA regulates, creating a political stalemate.

Crawford says he's willing to stay on the job as long as the Bush administration wants, but he hasn't heard their plans. "I have no expectation ... of being named commissioner."

His appointment to the post of deputy commissioner was seen as a way to get a Bush-supported official in at least the role of acting head. Crawford has the strong support of Tommy Thompson, secretary of health and human service. Many observers are now speculating that he will eventually be nominated for the slot.

"(Naming an FDA head) is a priority issue," said HHS spokesman Bill Pierce. Asked if Crawford was in the running for the past, Pierce was diplomatic. "The secretary and the president think Dr. Crawford is doing a great job."

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